Kornimate/medical-research-clean huggingface dataset:
evaluation of the pillcam™ colon capsule endoscopy (pcce-2) in pediatric ulcerative colitis

Conditions: Pediatrics, Colon Capsule Endoscopy

Summary: this prospective pilot study of 30 pediatric subjects, that are indicated for standard colonoscopy due to follow-up of ulcerative colitis (uc), examines the given diagnostic system and the pillcam colon capsule in comparison to standard colonoscopy. this study aims 1. to evaluate and compare the accuracy of pillcam ™ colon capsule endoscopy (pcce) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis. 2. to evaluate the safety of pillcam ™ colon capsule endoscopy (pcce) in pediatric age.


Eligibility criteria:
eligibility ages eligible for study: 6-18 years genders eligible for study: both accepts healthy volunteers: no inclusion criteria: subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study: * diagnosis of uc made at least 3 months before the enrolment; * subject was referred for standard colonoscopy and endoscopic follow-up in ulcerative colitis * signed informed consent. exclusion criteria the presence of any of the following will exclude a subject from study enrollment: * subject has dysphagia * subject has renal insufficiency * subject is known or suspected structuring cd. * subject has a cardiac pacemaker or other implanted electro medical devices. * subject is expected to undergo mri examination within 7 days after ingestion of the capsule. * subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
effect of gastric bypass surgery on diabetes status and microvascular complications in obese type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus; Obesity; Diabetic Retinopathy; Diabetic Nephropathy

Summary: this study evaluates the long-term benefits of roux-en-y gastric bypass (rygb) on type 2 diabetes mellitus, focussing on the prevalence and predictors of t2dm improvement and remission after rygb, and subsequently relapse of type 2 diabetes mellitus after rygb. moreover, the study evaluates the possible effect of rygb on diabetic microvascular complications such as nephropathy and retinopathy. finally, the study provides insight into the factors influencing glucose-insulin homeostasis after rygb, including altered microbiota diversity and bile acid levels.

one hundred danish type 2 diabetes mellitus (t2dm) patients who underwent roux-en-y gastric bypass surgery (rygb) between 2006-2011 will be evaluated clinically together with 50 t2dm patients, matched on gender, age, presurgical body mass index, and diabetes duration. the clinical follow-up consists of a physiological check-up, a thorough paraclinical work-up, and a whole body dual-energy x-ray absorptiometry (body composition and bone mineral density) a peripheral quantitative compute tomography (hr-pqct), stool samples (microbiota), ophthalmological examination including retina photo, and a questionaire. more over, a liquid meal test with sampling of total bile acids, fibroblast growth factor 19 and 21 (fgf 19 and fgf 21), plasma glucose, and insulin will be performed on a smaller part of the patients.

Eligibility criteria:
inclusion criteria: * capable * type 2 diabetes mellitus * speaks and understands danish * presents written concent * cases must be roux-en-y operated between 2006-2011. exclusion criteria: * converted roux-en-y * chronic inflammatory bowel disease * ischemic heart disease * liver disease * cholecystectomy. controls can not be bariatric operated.

Keywords: roux-en-y gastric bypass obesity type 2 diabetes mellitus diabetic nephropathy diabetic retinopathy
dexamethasone administered via the epidural catheter as an adjunct in patients undergoing cesarean delivery

Conditions: Post Operative Pain

Summary: this study will evaluate the ability of dexamethasone to enhance labor epidurals when administered as an adjunct to local anesthetics via an epidural catheter. patients undergoing elective cesarean sections will be randomized into three groups, each receiving the same combined spinal epidural (cse). at surgical closure, group 1 will receive 10cc bupivacaine 0.0625%, group 2 will receive 10cc bupivacaine 0.0625% +4mg dexamethasone, and group 3 will receive 10cc bupivacaine 0.0625% + 8mg dexamethasone (4mg). vas, sedation, nausea, and satisfaction scoring will be measured on patient follow-up to compare the outcomes of the different treatment groups.

this study will evaluate the ability of dexamethasone to enhance labor epidurals when administered as an adjunct to local anesthetics via an epidural catheter. patients undergoing elective cesarean sections will be randomized into three groups using a random allocation table. group assignment will be performed by opening a previously prepared numbered opaque envelope containing the assignment. each group will receive the same combined spinal epidural (cse) containing 10-12mg hyperbaric bupivacaine, 150mcg preservative-free morphine, and 15mcg fentanyl. at surgical closure, group 1 will receive 10cc bupivacaine 0.0625%, group 2 will receive 10cc bupivacaine 0.0625% +4mg dexamethasone, and group 3 will receive 10cc bupivacaine 0.0625% + 8mg dexamethasone (4mg). in order to maintain this as a double-blinded study, the patient will not be told which medication was administered and the drug will be given by one anesthesiologist and the patient follow-up will be performed by a different anesthesiologist. vas, sedation, nausea, and satisfaction scoring will be measured on patient follow-up to compare how these outcomes compare between the different treatment groups.

Eligibility criteria:
inclusion criteria: * parturients in their 3rd trimester who are receiving a planned cesarean delivery * primiparous and multiparous pregnancies * american society of anesthesia (asa) classes 1, 2 , and 3 exclusion criteria: * patients for whom neuraxial anesthesia was either declined, unsuccessful, or contraindicated * gestational diabetics * diabetics * patients allergic to dexamethasone, local anesthetics, or opioids * patients that are immunosuppressed * patient who received systemic steroids within the preceding 48 hours

Keywords: dexamethasone labor epidural cesarean section
arthroscopic treatment of partial rotator cuff tears in shoulder joint

Conditions: Rotator Cuff Tears

Summary: a retrospective analysis was performed on patients with partial-thickness rotator cuff tendon tears who underwent arthroscopic surgery from august 2006 to december 2011. to evaluate functional outcomes and tendon healing after arthroscopy.

to study the surgical method and clinical effect of arthroscopic treatment of rotator cuff tendon tear. retrospective analysis was performed on patients with rotator cuff tendon tears who underwent arthroscopic surgery from august 2006 to december 2011. preoperative x-ray and mri were performed. rotator cuff repair was performed during the operation. ucla shoulder scoring scale was used to evaluate the shoulder joint at preoperative and final follow-up.

Eligibility criteria:
inclusion criteria: * from august 2006 to december 2011, patients with partial-thickness rotator cuff tendon tears who underwent arthroscopic surgery in our department and were successfully followed up. exclusion criteria: * patients with frozen shoulder and shoulder joint instability.
comparison of esp block and stap plane block

Conditions: Postoperative Pain

Summary: in order to effectively manage postoperative analgesia in patients planned to undergo elective laparoscopic cholecystectomy, patients will be divided into 2 (two) groups and informed consent forms will be obtained after the necessary information is provided so that both groups can be included in the study. in the group planned to undergo erector spinae plane block, erector spinae plane block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative pca analgesia will be applied. in patients who will undergo subcostal transversus abdominis plane block, subcostal tap block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative pca analgesia will be applied. the patients' perioperative pain will be monitored with nol (nociception level) monitor. remifentanil dose will be adjusted to keep the nol level between 10 and 25. after the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this process will be compared. in this way, it is aimed to show that the analgesic method can be used effectively in the follow-up of pain management by comparing the erector spina plane block and the subcostal transversus abdominis plane block as an effective analgesic application in laparoscopic cholecystectomy operations.


Eligibility criteria:
inclusion criteria: * patients who will undergo laparoscopic cholecystectomy: * 18-75 years old * asa i-ii-iii patients exclusion criteria: * use of anticoagulant drugs * known allergy to drugs to be used * infection in the area where the block will be performed * patient's reluctance

Keywords: regional anesthesia erector spinae plane block subcostal transversus abdominis plane block
farial nerf mri in the preoperative assessment of parotide tumors

Conditions: Parotid Tumor

Summary: 1. st visit: inclusion, 3tesla injected parotid mri performed as part of routine care for characterization, to which two specific high resolution sequences will be added. evaluation of the exact position of the parotid tumor relative to the trunk of the facial nerve and its first branches, classification into two categories: on contact (≤ 5 mm) or at a distance (\> 5 mm). 2. nd visit: surgical intervention of the parotid tumor. the surgeon will specify the same data as that collected by the radiologists after the mri. 3. rd visit: post-operative consultation in the week following the intervention. the surgeon will look for the occurrence of post-operative facial paralysis.


Eligibility criteria:
inclusion criteria: * patient over 18 years old * patient candidate for first line surgery for a parotid tumor * parotid tumor located near the trunk of the facial nerve and or its first branches of division according to the clinical examination of the ent surgeon and the imaging data * affiliate or beneficiary of a social security scheme * written consent to participate in the study exclusion criteria: * personal history of parotid homolateral surgery * absolute or relative contraindication to mri * known hypersensitivity to gadolinic contrast media * pre or post operative period of a liver transplant * patient benefiting from a legal protection measure * pregnant or lactating woman * patient who has already benefited from a preoperative mri to characterize a complete, well conducted and interpretable parotid lesion
platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil in recurrent nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: local control rates of nasopharyngeal carcinoma are increasing, but 15% of patients still have local recurrence within 5 years after initial treatment. systematic treatment based on chemotherapy has become the mainstream approach for recurrent nasopharyngeal carcinoma which is intolerant to local therapy. we sought to find an efficient chemotherapy regimen with high tolerance according to the characteristics of chemotherapy drugs, that is, to explore the efficacy and safety of platinum plus 5-fluorouracil with continuous intravenous infusion at a low dose for a long term.

nasopharyngeal carcinoma (npc) is a malignant tumor of the nasopharyngeal epithelium with high sensitivity to ionizing radiation, but failure in local control was observed in approximately 15% of patients. chemotherapy is the cornerstone of the treatment of recurrent npc. many studies were aimed at the systemic treatment of recurrent npc, but most of them were retrospective studies or phase ii trials with small samples. platinum-containing doublet chemotherapy is generally regarded as the standard treatment for recurrent npc. after a multicenter phase iii randomized clinical trial was published in 2016, gemcitabine plus cisplatin is recommended, however, less than 60% of patients could complete the treatment in the trail. finding a proper regimen with promising efficacy results as well as high tolerance is still a big challenge. cisplatin plus 5-fluorouracil (pf) is a classical regimen widely used in recurrent npc. the continuous infusion of 5-fluorouracil with low dose was investigated in esophagus carcinoma, rectal carcinoma and prostate carcinoma with encouraging outcome and acceptable toxicity. whereas, data of platinum containing chemotherapy with low-dose continuous infused 5-fluorouracil in recurrent npc was absent. in this study, we aimed to investigate the antitumor activity of platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil (pfll).

Eligibility criteria:
inclusion criteria: - patients involved in our study were patients who had histologically or cytologically confirmed npc with diagnosed recurrent npc during 2006-2018 and receiving treatment in our hospital. exclusion criteria: * age \ 70 years old * pathologic type unknown or except type i-iii of world health organization classification * never underwent platinum-based chemotherapy * lack of information about t classification and n classification when metastasis * lost follow-up within one month from the start of treatment for metastasis * with other malignances
long term effect of an education and training program for patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a parallell group study comparing the effect of an education program with an education and training program for patients with copd. 30 participants in each group. participants self-select which group they wanted to be in. main outcome is sgrq (a hqol for patients with copd).


Eligibility criteria:
inclusion criteria: * patients diagnosed with copd (fev1\<75% of expected) who have the ability to conversation and active participation will be included. exclusion criteria: -

Keywords: patient education
first-in-human study of rly-5836 in advanced breast cancer and other solid tumors

Conditions: PIK3CA Mutation; Solid Tumor, Adult; HER2-negative Breast Cancer; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Unresectable Solid Tumor; Hormone Receptor Positive Tumor

Summary: this is a phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (mtd), recommended phase 2 dose (rp2d), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of rly-5836 in advanced solid tumors in participants harboring a pik3ca mutation in blood and/or tumor per local assessment. the study consists of 2 parts, a dose escalation (part 1) and a dose expansion (part 2).


Eligibility criteria:
inclusion criteria: patient has ecog performance status of 0-1 one or more documented primary oncogenic pik3ca mutation(s) in blood and/or tumor per local assessment rly-5836 single agent arm key inclusion criteria * disease that is refractory to standard therapy, intolerant to standard therapy, or participant has declined standard therapy. * a histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor combination arms key inclusion criteria * males, postmenopausal females, or pre-/perimenopausal females previously treated with gonadotropin-releasing gnrh agonist at least 4 weeks prior to start of study drug with histologically or cytologically confirmed diagnosis of hr+, her2- unresectable or metastatic breast cancer that is not amenable to curative therapy. * had previous treatment for advanced or metastatic breast cancer with antiestrogen therapy including, but not limited to, selective estrogen receptor degraders (e.g., fulvestrant), selective estrogen receptor modulators (e.g., tamoxifen), and aromatase inhibitors (ai) (letrozole, anastrozole, exemestane) * part 1: prior pi3kα inhibitor treatment is allowed if taken for \< 14 days and not discontinued due to disease progression, hypersensitivity, or ≥ grade 3 teaes. exclusion criteria: * part 2: prior treatment with pi3kα inhibitors. * type 1 or type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥140 mg/dl and glycosylated hemoglobin (hba1c) ≥7.0%.
observatory of psychiatric symptoms and their somatic causes in urgent medical care

Conditions: Neurologic Disorder; Psychiatric Disorder

Summary: use of emergency department for psychiatric symptoms always addresses the question of a potential somatic cause to the symptoms. despite the wide-spread use of standard biology test and systematic brain imaging (for a first episode), there are still up to 5% of patients sent in psychiatric wards that actually have a somatic explanation to their symptoms which induces an important delay in the diagnostic assessement we hypothesized that simple neurological clinical examination along with fast psychometric screening tests in the emergency room (er) could help the physicians to better screen the patients and thus prevent inaccurate post-emergency orientation. every patient visiting the er for psychiatric symptoms will be included. the usual physical examination by the er physician will be associated with two psychometric tests (namely the clock-drawing test and frontal assessment battery test). the follow up will be made after 3 months in order to have the final diagnosis. neurological data and data from the fab test and the clock-drawing test will be compared between patients who were finally given a psychiatric diagnosis versus patients with a somatic diagnosis at the end of the follow up period.


Eligibility criteria:
inclusion criteria: * age\> 18 years old * patient consulting the emergency room for psychiatric recourse * benefiting from a consultation with a psychiatrist in the emergency room * patient affiliated to a social security scheme exclusion criteria: * pregnant or breastfeeding women * patient objecting to the conduct of this study and the collection of health data * patient with motor disorders preventing the performance of a test requiring a pencil * patient sedated before treatment in the emergency room * patient with visual disturbances
controlled study of the effect of xenaderm® ointment vehicle versus white petrolatum on healing

Conditions: Wounds

Summary: the objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle.


Eligibility criteria:
inclusion criteria: subjects will be considered qualified for enrollment if they: * provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the investigator, sub-investigator or other designated study staff member has explained the study procedures, risks and contact information. * are male or female, ≥ 18 years of age, of any race. * are willing to attend all required study visits, and to comply with study procedures. * meet none of the exclusion criteria (any single exclusion criterion which is met by a potential subject will disqualify that subject from participation in this study). exclusion criteria: subjects will be considered not qualified for enrollment if they: * have a history of dermatomyositis, systemic sclerosis, scleroderma, sjögren's syndrome, systemic lupus erythematosis, discoid lupus, ehler's danlos disease, icthyosis vulgaris, vasculitis or bleeding disorders (coagulopathies). * have any dermatologic disease which may be aggravated or provoked by the wounding procedure, such as lichen planus, psoriasis or vitiligo. * have fitzpatrick scale skin type 6 (never sunburns, deeply pigmented). * are at risk of keloid or hypertrophic scar formation, based on personal history, family history, or brief skin exam (conducted at the screening visit to look for keloids or hypertrophic scars). * have been treated within the last three months for uncontrolled diabetes mellitus, peripheral vascular disease, vitamin c deficiency, connective tissue disorders, or any other disease process that impedes wound healing. * are taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs. * are using topical glycolic acid products, alpha-hydroxy acid products, retinoids or chemical peel agents in the treatment areas. * are using systemic steroids or immunosuppressant agents, or have used these drugs within the past three months.

Keywords: white petrolatum xenaderm vehicle partial thickness wounds healing cryo-surgery
treatment with probiotics (saccharomyces boulardii) and its role in bacterial translocation and immune reconstitution in vih infection.

Conditions: HIV -1 Infection

Summary: objectives: main: to evaluate the parameters of microbial translocation after treatment with probiotics (saccharomyces boulardii) in hiv+ patients and its role on immune reconstitution and the changes in gut microbiota composition. secondary objectives: 1) to analyze the progress of immune activity markers after the administration of probiotics. 2) to determine the improvement of cd4+ lymphocytes and hiv viral load in patients after taking probiotics. methods: design: a prospective randomized open controlled double-blinded trial, to be performed at a tertiary care hospital in barcelona. subjects: chronic hiv infected patients. sample size: 44 cases. they´ll be divided in 2 groups: (1) patients with cd4 +\> 400 cells / ml and undetectable viral load for more than two years (22 cases) and (2) patients with immunodiscordancy, defined as patients with cd4 + t cells lower than 350 cells / ml despite 4-7 years of effective antiretroviral therapy. (22 cases). intervention: patients were randomized in 2 subgroups: (a) they´ll receive daily oral supplementation with s. boulardii for 3 months and (b) they ´ll receive placebo. variables: bacterial lipopolisaccharide levels measured by the lipid-binding protein (lbp), parameters of immune activation in plasma (soluble cd14, ifn-υ, tnf-alpha, il (interleukine)-2, il-5, il-6, il-12)and gut microbiota composition prior to the use of probiotics (baseline), at 3 and 6 months. immunological and clinical data. outcome measures: quantification of bacterial translocation levels, markers of activity and immune recovery. analysis: comparison of variables before and after the intervention. the analysis will be performed by biological and immunological effectiveness.


Eligibility criteria:
inclusion criteria: * patients with chronic hiv infection and viral load undetectable \> two years with stable art cd4\> 400 cells / ml. * patients with chronic hiv infection and viral load undetectable\> two years with stable art cd4 \<350 cells / ml. * inform consent signed. * aged between 18- no limit. exclusion criteria: * patients who receive or have received in the past 6 months food supplements containing probiotics. * patients who have received antibiotic treatment in the last two months * patients who are poor presupposes adherence to dietary supplements. * patients who have changed the tar in the last three months.

Keywords: probiotic hiv microbial translocation inflammation microbiota composition